Aging Veterans May Have New Options As VA And Longeveron Make Progress On Clinical Research Of Aging Frailty Treatment

The U.S. Department of Veterans Affairs (VA) partnered with Longeveron Inc. LGVN to explore the clinical-stage biotech’s novel cell therapies as a potential treatment for aging frailty. 

Affecting an estimated 30% of U.S. veterans older than 65, aging frailty is characterized by decreased muscle mass, unintentional weight loss, cognitive impairment and other symptoms that can make daily life increasingly difficult.

The collaboration led to a Phase 2 clinical study of Lomecel-B, Longeveron’s leading drug candidate, at the VA Medical Center in Miami. This collaboration could be an important step for aging populations around the world.

Veterans Are At A Reportedly Higher Risk Of Aging Frailty

As humans age, the cells that make up organs and tissue age, too, making it harder to repair damage to the body. As a result, some loss of strength and functionality is normal. 

But aging frailty is different from normal aging. It’s an extreme form of the process, likely linked to chronic low-level inflammation in which a person’s physical and cognitive functions decline even faster than usual. The frequent exhaustion and increasing weakness can make even small daily activities overwhelming, and the risk of minor injuries leading to serious debility is high. 

"Frailty is highly prevalent among older veterans.  Research has shown that this condition is associated with significant disability, healthcare utilization, morbidity, and mortality in older adults,” said Jorge G. Ruiz, M.D., F.A.C.P., Associate Director for Clinical Affairs, Geriatric Research, Miami Veteran's Administration Medical Center.

High rates of aging frailty among veterans have motivated the VA to invest heavily into finding meaningful solutions for helping its members regain physical and cognitive strength so they can enjoy a healthier, more active lifestyle in their golden years.

While veterans are even more likely to experience frailty as they age, 15% of the general U.S. population age 65 and older are frail, and an estimated 45% are “prefrail,” meaning they’re at high risk of becoming frail within a few years.

Even with rates as high as this, no treatments that slow, reverse, or prevent aging frailty have been approved by the Food and Drug Administration (FDA). Right now, the standard of care largely involves diet and exercise recommendations that patients may or may not employ into their daily lives .

How Longeveron’s Lomecel-B Could Help Aging Veterans

The lack of FDA-approved therapies to combat aging frailty has made filling that gap a priority for the VA as well as the National Institute of Health (NIH). The collaborative research with Longeveron at the Miami VA Medical Center, for example, is funded in part by a $3.8 million NIH grant. 

The grant was awarded on the basis of the biotech’s earlier clinical research on Lomecel-B indicating the potential to improve physical functioning in patients with aging frailty. 

The drug candidate is composed of medicinal signaling cells (MSCs) derived from donated bone marrow. These cells have been shown to have multiple modes of action over decades of research. One key aspect is that they seem to reduce inflammation. In addition they appear to support the health of a variety of cells.  

“Stem cell therapies could represent a significant advance in reducing the burden of frailty in our veteran population," Dr. Jorge Ruiz of Miami Veterans Administration Medical Center said in a statement on the grant. 

Similar cell therapies are being explored for other conditions, including Bristol Myers Squibb Co.’s BMY research using MSCs to treat cancer or AgeX Therapeutics Inc.’s AGE research using MSCs to moderate the adverse effects of chemotherapy and radiation treatments.

But Longeveron could be pioneering the approach as a treatment for aging frailty. Using these cells that can affect disease through a variety of mechanisms, Lomecel-B may have the potential to trigger the body’s repair and regeneration responses while also reducing the inflammation that causes the damage in the first place. 

In the topline data from the Phase 2b study in Miami, for example, veterans who received a single infusion of Lomecel-B saw some improved physical function across a range of measures. 

The primary endpoint of the study was to measure changes in patients’ performance on a six-minute walk test. For the Lomecel-B group, walking distance in the six-minute walk test when measured 9 months after treatment increased by 40 to 63 meters on average, compared to just 8 meters for the placebo group. Moreover, the higher the dose a patient received, the greater the improvement on this endpoint. 

As more data is added to these clinical results, Longeveron states that it hopes to move as quickly as possible toward FDA approval of the therapy for aging frailty.

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